Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Lactose free probiotic yogurt
Sponsored by
About this trial
This is an interventional prevention trial for Irritable Bowel Syndrome
Eligibility Criteria
Inclusion Criteria:
- Recreational athlete (defined as a person who is physically active but does not train for competition at the same level of intensity and focus as a competitive athlete )
- Diagnosed with irritable bowel syndrome
Exclusion Criteria:
- Other gastrointestinal diseases such as inflammatory bowel disease, other serious chronic diseases, coeliac disease, have an allergy to product ingredients (milk), diabetic and pregnant or breastfeeding.
- unable to fast overnight, undergoing antibiotic therapies, bowel preparation for investigative procedures, and change to IBS medication during the past month prior to data collection.
Sites / Locations
- University of Central LancashireRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Diet A - Lactose free probiotic yogurt
Diet B - Lactose free yogurt (non-probiotic)
Arm Description
Plain flavoured lactose free probiotic yogurt (contains Lactobacillus acidophilus and Bifidobacterium lactis)
Plain flavoured lactose free yogurt (contains only starter cultures)
Outcomes
Primary Outcome Measures
IBS Severity Score Scale (IBS-SSS)
The IBS-SSS is a questionnaire commonly used to evaluate the severity of IBS symptoms. There are five questions (i) abdominal pain intensity; (ii) abdominal distension; (iii) bowel habit dissatisfaction, (iv) life interference and (v) abdominal pain frequency (defined as number of days with pain during the last 10 days). Higher scores indicate more severe symptoms.
Secondary Outcome Measures
IBS Quality of Life (IBS-QOL)
The IBS-QOL is a questionnaire to assess the burden of IBS on participants' everyday functioning and wellbeing. The instrument consists of 34 items assessing wellbeing across eight subscales: dysphoria, activity interference, body image, social reaction, health worry, food avoidance, relationships and sexual. Respondents rate each item on a 5-point scale ranging from 1 (Not at all) to 5 (Extremely / A great deal). All items are summed to calculate the IBS-QOL total score. It is then converted to a scale of 0-100 using the following formula: [(sum of items - lowest possible score) / possible raw score range] x 100 The higher the score, the higher the health-related quality of life.
Stool frequency and consistency
Participants are provided with forms to record their stool frequency (e.g. once / twice a day) and stool consistency (e.g. Type 1, 2...7) based on Bristol stool chart.
Full Information
NCT ID
NCT05001997
First Posted
July 26, 2021
Last Updated
August 3, 2021
Sponsor
University of Central Lancashire
1. Study Identification
Unique Protocol Identification Number
NCT05001997
Brief Title
Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome
Official Title
Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Central Lancashire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Irritable Bowel Syndrome (IBS) is a gastrointestinal disorder defined by recurrent abdominal pain, bloating, abdominal distention and altered bowel habits. IBS is common among athletes and can impair performance. IBS was found to be prevalent in 9.8% (n=430) of endurance athletes. The condition is associated with significantly reduced quality of life. IBS patients often attribute their gastrointestinal effects to lactose intolerance (LI) and may avoid/limit intake of dairy products. As LI and IBS share similar symptoms, IBS patients may wrongly attribute lactose intolerance as one of the causative factors and avoid dairy products altogether. Self-imposed reductions in consumption of dairy products could reduce calcium intake leading to reduced bone mineral density. This study aims to determine the prevalence of lactose malabsorption among athletes suffering from IBS and the potential of lactose free probiotics dairy products in alleviating gastrointestinal symptoms. The inclusion of probiotics dairy products in patients' diet will be beneficial in the long term to ensure adequate intake of calcium.
Detailed Description
Irritable Bowel Syndrome (IBS) is a common, global, functional gastrointestinal disorder. It affects a significant number of people, i.e. between 9 - 23% of the world's population. The aetiology and diagnosis of IBS is poorly understood due to the complexity, heterogeneity and incomplete understanding of the pathology, thus well-defined treatments and protocols are lacking. For example, impaired motility and sensitivity, changes in gut microbiome, increased permeability, low-grade inflammation, gut endocrine cells, and alterations in the gut-brain axis, all of which are identified to play a pivotal role in the pathophysiology of IBS. Thus, it may be challenging to identify the cause of a patient's symptoms as the pathology is not fully understood. IBS can also further be divided into four subtypes based on a patient's stool patterns: constipation-predominant (IBS-C), diarrhoea-predominant (IBS-D), mixed diarrhoea and constipation (IBS-M) and those whose bowel habits cannot be identified but meet the criteria (IBS-U).
Dietary modifications in treating IBS have also received significant recognition, as many patients report that foods appear to induce or exacerbate their symptoms, thus diet intervention may be a very effective tool in the symptom management of IBS. Strategies to relief symptoms include consuming a low fermentable oligosaccharides, disaccharides, monosaccharides, and polyol (FODMAP) diet, inclusion of prebiotics and probiotics in diet. Probiotics are defined as "live microorganisms that when administered in adequate amounts, confer a health benefit to host". Previous studies suggest that consumption of probiotics help to alleviate symptoms among IBS patients. However, there is still a lack of probiotic intervention studies using lactose-free dairy products to determine the efficacy in relieving IBS symptoms. The aims of this study are (i) to determine the prevalence of lactose malabsorption among athletes suffering from IBS and (ii) to evaluate the potential of lactose free probiotics dairy products in alleviating gastrointestinal symptoms among IBS patients.
Subject recruitment Twelve to 15 recreational athletes (age > 18 years) with diagnosed irritable bowel syndrome will be recruited. A recreational athlete is defined as a person who is physically active but does not train for competition at the same level of intensity and focus as a competitive athlete. Participants will be recruited from the North West IBS support group. The study will also be opened to staff and students at the university.
Hydrogen Breath Test Participants will be asked to follow an overnight (12 hour) fasting period, not to smoke or vape for at least 24 hours prior to the test and not to exercise for at least 1 hour before taking the test. Breath testing will be conducted in Nutrition and Health Suite, Darwin Building, University of Central Lancashire to determine the baseline hydrogen breath concentration using a portable breath analyser. Participants will then be provided with 400 ml semi-skimmed milk for consumption following baseline sampling. Subsequent breath samples will then be collected for re-testing every 15 minutes for 3 hours. Lactose malabsorption is present if the peak of hydrogen breath excretion over the baseline is ≥20ppm.
Lactose-free dairy products Participants will be randomised using computer random allocation sequence into either the intervention group (lactose free probiotic yogurt) or the control group (lactose free, non-probiotic yogurt). The lactose free probiotic yogurt and lactose free non-probiotic yogurt (control) will be purchased and stored at the laboratory refrigerator the day before the testing. Only lactose free probiotic yogurt containing cultures such as Lactobacillus acidophilus and Bifidobacterium lactis will be selected. Participants will be asked to consume 125g of lactose free products daily for 7 days, followed by 1-week washout period and crossover to alternate treatment for 7 days.
Questionnaires
Participants will be asked to complete the following questionnaires at Week 0 (before the start of the dietary intervention), end of Week 1 (upon completion of 1st dietary intervention), end of Week 2 (upon completion of washout period) and end of Week 3 (upon completion of 2nd dietary intervention):
i) Participants' characteristics, records of exercise, stool frequency and consistency ii) IBS Severity Score Scale (IBS-SSS) iii) IBS Quality of Life (IBS-QOL)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single-blinded, randomised crossover study
Masking
Participant
Masking Description
All yogurt labels will be covered or masked with corrugated sleeves
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diet A - Lactose free probiotic yogurt
Arm Type
Active Comparator
Arm Description
Plain flavoured lactose free probiotic yogurt (contains Lactobacillus acidophilus and Bifidobacterium lactis)
Arm Title
Diet B - Lactose free yogurt (non-probiotic)
Arm Type
Placebo Comparator
Arm Description
Plain flavoured lactose free yogurt (contains only starter cultures)
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactose free probiotic yogurt
Intervention Description
Probiotics are non-pathogenic, live microbes that when eaten or administered In adequate amount, it confer health benefits to host. Only lactose free probiotic yogurt containing cultures such as Lactobacillus acidophilus and Bifidobacterium lactis will be selected.
Primary Outcome Measure Information:
Title
IBS Severity Score Scale (IBS-SSS)
Description
The IBS-SSS is a questionnaire commonly used to evaluate the severity of IBS symptoms. There are five questions (i) abdominal pain intensity; (ii) abdominal distension; (iii) bowel habit dissatisfaction, (iv) life interference and (v) abdominal pain frequency (defined as number of days with pain during the last 10 days). Higher scores indicate more severe symptoms.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
IBS Quality of Life (IBS-QOL)
Description
The IBS-QOL is a questionnaire to assess the burden of IBS on participants' everyday functioning and wellbeing. The instrument consists of 34 items assessing wellbeing across eight subscales: dysphoria, activity interference, body image, social reaction, health worry, food avoidance, relationships and sexual. Respondents rate each item on a 5-point scale ranging from 1 (Not at all) to 5 (Extremely / A great deal). All items are summed to calculate the IBS-QOL total score. It is then converted to a scale of 0-100 using the following formula: [(sum of items - lowest possible score) / possible raw score range] x 100 The higher the score, the higher the health-related quality of life.
Time Frame
3 weeks
Title
Stool frequency and consistency
Description
Participants are provided with forms to record their stool frequency (e.g. once / twice a day) and stool consistency (e.g. Type 1, 2...7) based on Bristol stool chart.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recreational athlete (defined as a person who is physically active but does not train for competition at the same level of intensity and focus as a competitive athlete )
Diagnosed with irritable bowel syndrome
Exclusion Criteria:
Other gastrointestinal diseases such as inflammatory bowel disease, other serious chronic diseases, coeliac disease, have an allergy to product ingredients (milk), diabetic and pregnant or breastfeeding.
unable to fast overnight, undergoing antibiotic therapies, bowel preparation for investigative procedures, and change to IBS medication during the past month prior to data collection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Soon
Phone
+441772201201
Email
jmsoon@uclan.ac.uk
Facility Information:
Facility Name
University of Central Lancashire
City
Preston
ZIP/Postal Code
PR1 2HE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan M Soon
Phone
+441772201201
Email
jmsoon@uclan.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome
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